Pediarix

"Thanks to effective vaccine, the United States has been polio-free since 1979. But poliovirus is still a threat in some countries. Be part of the success story and get your child vaccinated on schedule.

The diphtheria toxin is produced by growing Corynebacterium
diphtheriae in Fenton medium containing a bovineextract. Tetanus toxin is
produced by growing Clostridium tetani in a modified Latham medium
derived from bovine casein. The bovine materials used in these extracts are
sourced from countries which the United States Department of Agriculture (USDA)
has determined neither have nor are at risk of bovine spongiform encephalopathy
(BSE). Both toxins are detoxified with formaldehyde, concentrated by
ultrafiltration, and purified by precipitation, dialysis, and sterile
filtration.

The 3 acellular pertussis antigens (PT, FHA, and pertactin)
are isolated from Bordetella pertussis culture grown in modified
Stainer-Scholte liquid medium. PT and FHA are isolated from the fermentation
broth; pertactin is extracted from the cells by heat treatment and
flocculation. The antigens are purified in successive chromatographic and
precipitation steps. PT is detoxified using glutaraldehyde and formaldehyde.
FHA and pertactin are treated with formaldehyde.

The hepatitis B surface antigen (HBsAg) is obtained by
culturing genetically engineered Saccharomyces cerevisiae cells, which
carry the surface antigen gene of the hepatitis B virus, in synthetic medium.
The surface antigen expressed in the S. cerevisiae cells is purified by
several physiochemical steps, which include precipitation, ion exchange
chromatography, and ultrafiltration.

The inactivated poliovirus component of PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) is an
enhanced potency component. Each of the 3 strains of poliovirus is individually
grown in VERO cells, a continuous line of monkey kidney cells, cultivated on
microcarriers. Calf serum and lactalbumin hydrolysate are used during VERO cell
culture and/or virus culture. Calf serum is sourced from countries the USDA has
determined neither have nor are at risk of BSE. After clarification, each viral
suspension is purified by ultrafiltration, diafiltration, and successive
chromatographic steps, and inactivated with formaldehyde. The 3 purified viral
strains are then pooled to form a trivalent concentrate.

Diphtheria and tetanus toxoid potency is determined by
measuring the amount of neutralizing antitoxin in previously immunized guinea
pigs. The potency of the acellular pertussis components (inactivated PT and
formaldehyde-treated FHA and pertactin) is determined by enzyme-linked
immunosorbent assay (ELISA) on sera from previously immunized mice. Potency of
the hepatitis B component is established by HBsAg ELISA. The potency of the
inactivated poliovirus component is determined by using the D-antigen ELISA and
by a poliovirus neutralizing cell culture assay on sera from previously
immunized rats.

Each 0.5-mL dose also contains 4.5 mg of NaCl and aluminum
adjuvant (not more than 0.85 mg aluminum by assay). Each dose also contains
≤ 100 mcg of residual formaldehyde and ≤ 100 mcg of polysorbate
80 (Tween 80). Neomycin sulfate and polymyxin B are used in the polio vaccine
manufacturing process and may be present in the final vaccine at ≤ 0.05
ng neomycin and 0.01 ng polymyxin B per dose. The procedures used to
manufacture the HBsAg antigen result in a product that contains ≤ 5% yeast
protein.

What are the possible side effects of this vaccine (Pediarix)?

Your child should not receive a booster vaccine if he or she had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects your child has after receiving this vaccine. When the child receives a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Becoming infected with diphtheria, hepatitis B, pertussis, polio, or tetanus is much more dangerous to your child's health than receiving the vaccine to protect against these diseases. Like any medicine, this vaccine can cause side effects, but the risk of...